Trials / Completed
CompletedNCT00225706
A Study of Caldolor in Hospitalized Febrile Pediatric Patients
Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF \[37.0ºC\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Caldolor |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2007-08-01
- Completion
- 2007-08-01
- First posted
- 2005-09-26
- Last updated
- 2010-04-12
Locations
3 sites across 3 countries: United States, Panama, South Africa
Source: ClinicalTrials.gov record NCT00225706. Inclusion in this directory is not an endorsement.